Passage of the 21st Century Cures Act: What It Means

provides more than $4.8 billion over 10 years to the National Institutes of Health (NIH) for the Precision Medicine Initiative, Cancer Moonshot, BRAIN Initiative, and regenerative medicine using adult stem cells.

provides the FDA with $500 million over 10 years to move drugs and medical devices to patients more quickly, while maintaining safety and effectiveness standards.

encourages HHS to carry out a “Precision medicine Initiative” to augment efforts to address disease prevention, diagnosis, and treatment.

Why does it matter?

$1.5 billion of the funds will fund research to advance precision medicine.

$1.8 billion will fund cancer research.

The legislation supports broader, more collaborative development, qualification, and utilization of biomarkers that help assess how a therapy is working earlier in the process.

The Cures Act includes creation of a “Next Generation of Researchers Initiative” in the Office of the NIH director to improve opportunities for new researchers.

The act also establishes a review pathway at FDA for biomarkers and other drug-development tools that can be used to help shorten drug-development time and reduce the failure rate in drug development.

…and more.

What is SNMMI doing?

SNMMI plans to submit comments to the Centers for Medicare and Medicaid Services regarding the site-neutral policy that is included in the Cures Act. The society will work with other medical societies and stake-holder groups on these comments.

SNMMI is working to help streamline the FDA regulatory approval process for new and existing radiopharmaceuticals.

What’s next?

President Obama is expected to sign the Cures Act. A stop-gap funding bill being developed on the Hill is expected to include some initial funds.